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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

We've said it once, and we'll say it again: Finding and making sense of regulatory information is exceedingly difficult. Even in the US, where the US Food and Drug Administration (FDA) publishes massive amounts of data, the process is at best monotonous and at worst a colossal waste of time. Now one company's just-released piece of software is looking to fundamentally change that dynamic for the better.

The SOFIE System

The company is Graematter, a St. Louis-based startup we last profiled in May 2013 after it raised almost a million dollars in seed funding. Led by long-time regulatory affairs professional Melissa Walker*, the company's entire business model is built on the idea that the fire hose of information coming out of FDA can be filtered and made useful.

"There's an information overload coming out of FDA right now," Walker told Focus in May 2013. "The problem now is, how do you manage to find the information you need in these separate databases? It's extremely frustrating to do without the right tools."

Now Graematter has launched that "right tool," one it calls SOFIE.

Its boast: Do in just a few hours what might ordinarily take weeks to accomplish. Graematter CEO Merle Symes recounted one such tale to Focus when we caught up with him and Walker at the 2013 RAPS Regulatory Convergence conference in Boston, MA last week.

"One of the regulatory specialty law firms conducted an analysis last year, and they spent about a year developing the data for the analysis. Melissa [Walker] did it in about 15 minutes using the SOFIE system," said Symes. "It took them a long time, and by the time they actually processed it, the data they used was almost a year old."

Finding Efficiencies

And while that might be an example on the extreme end, Symes, formerly with Bausch + Lomb, said the experience of most companies using the system was hugely positive.

"The number one thing we've heard from our beta testers is, 'This has saved me so much time,'" he said. "Some of [the testers] said it took them 20% of the time it used to take them to do the same task. All of them said it at least halved the time they spent [on the same tasks]."

And it's not just the time being spent that's seen improvements, Graematter employees said-it's the quality of the results that do come back.

As it stands, searching FDA's databases is a laborious process, and it's easy to miss certain crucial documents.

"It's hugely difficult to use FDA's databases," explains Sharon Bishop, director of user experience at Graematter. "Already, we've had an instance where improved search functionality has saved an entire clinical trial because we were able to find an abandoned PMA."

"The ability to find predicate devices is just so much easier," added Symes.

New Ways of Searching Old Information

In other cases, SOFIE allows you to do searches in new ways that FDA's existing search functionality doesn't allow.

"One of the things you can do is find out how many 510(k)s have not made it out of the system," Walker says. "We don't know what happened to them because they're invisible, but you can take a period-say, a year-and query the number submitted versus the number that got cleared. Either the submissions were withdrawn, remain under review, not cleared for review, or something happened to them."

This, she adds, could help companies (or investors) determine if a filing is worth the risk involved.

Another useful functionality of the system: Tracking submissions even after they've been acquired by other companies. SOFIE can match searches by establishment codes, allowing regulatory professionals and investment types to better conduct due diligence activities.

Bishop adds that perhaps the most surprising use of their technology so far has been companies using SOFIE to look up their own filing information. "In some bases, that information wasn't properly maintained or wasn't easily available," she explained.

What's Next?

So what's next for Graematter and SOFIE? International markets, says Bishop. "We intend to expand to all regulated products all over the world."

Walker and Symes add that they're eager to add in new functionalities as well, including a mobile application and new sources of information.

For now, though, Graematter is focusing on working on improvements recommended by its beta testers, such as new export functionalities for Microsoft Excel and new reports for Warning Letters.

The SOFIE System is now available for sale, Merle said. Graematter declined to make the cost available to Focus, citing it as competitively sensitive information.

*Full Disclosure: Walker was once on the board of directors for Focus' parent organization, the Regulatory Affairs Professionals Society (RAPS). This had no impact on our decision to write about this topic.